Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1919

2. Registrant Information.

Registrant Reference Number: F-04-30-14

Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation

Address: 870 Technology Way

City: Libertyville

Prov / State: Illinois

Country: USA

Postal Code: 60048

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

30-APR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

30-APR-15

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No. 24977      PMRA Submission No.       EPA Registration No.

Product Name: Foray 48B

• Active Ingredient(s)
  • BACILLUS THURINGIENSIS BERLINER SSP KURSTAKI STRAIN HD-1

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: L/ha

10. Site pesticide was applied to (select all that apply).

Site: Forest - Woods / Forêt et boisés

Préciser le type: Aerial

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Per the applicator the product was aerial sprayed via a helicopter from approximately 100 feet. All sprays take place in the early morning and stop by 7:30 AM.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Hives

4. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Grandmother of (age) yr old girl. Toddler was staying overnight at her place sleeping with window open last Thursday , in morning she noticed a hives on childs cheek and arm. Called mother to bring Benadryl. Later that day, they played outside on lawn at grandmothers and started getting more hives over her legs and stomach area. Hives did settle down with Benadryl. Next day, mother was taking infant to see doctor at (name) hospital when the childs condition worsened on route. Mother called 911 and ambulance took child to (name) ER where she was seen, given epinephrine and adult doses of Benadryl and is now carrying an epi-pen. She doesnt know what caused the reaction and doesnt know what the child is allergic to. Wants to stay away from the treatment area in the meantime. Infant has had previous cases of hives but they didnt know what the cause was. The thought it might be the sunscreen they applied but their doctor didnt think so based on how the rash presented. Grandmother notes she has a hoarse voice as well but isnt sure it is related to the spray.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The area had been sprayed 15 days earlier. The child was not actually seen by family doctor, when presenting with the hives, only examined by ER doctor. Was seen later by the family doctor when the issues had subsided and has referred her to an allergist on an emergency basis

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Hoarseness
  • Specify - hoarse voice

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Grandmother of (age) yr old girl. Toddler was staying overnight at her place sleeping with window open last Thursday , in morning she noticed a hives on childs cheek and arm. Called mother to bring Benadryl. Later that day, they played outside on lawn at grandmothers and started getting more hives over her legs and stomach area. Hives did settle down with Benadryl. Next day, mother was taking infant to see doctor at (name) hospital when the childs condition worsened on route. Mother called 911 and ambulance took child to (name) ER where she was seen, given epinephrine and adult doses of Benadryl and is now carrying an epi-pen. She doesnt know what caused the reaction and doesnt know what the child is allergic to. Wants to stay away from the treatment area in the meantime. Infant has had previous cases of hives but they didnt know what the cause was. The thought it might be the sunscreen they applied but their doctor didnt think so based on how the rash presented. Grandmother notes she has a hoarse voice as well but isnt sure it is related to the spray.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The area had been sprayed 15 days earlier. The child was not actually seen by family doctor, when presenting with the hives, only examined by ER doctor. Was seen later by the family doctor when the issues had subsided and has referred her to an allergist on an emergency basis